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Tuesday, June 20 • 4:00pm - 5:15pm
#290: Quality Metrics: The Carrot or the Stick?

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Subsequent to the recently-revised (November 2016) Quality Metrics draft guidance, industry and regulatory experts will address the benefits and challenges posed by the newly revised draft guidance for various segments of the pharmaceutical industry, proposed solutions, different approaches to metrics analysis and implementation, and the quality culture as part of the metrics equation.

Learning Objectives

Discuss the advantages and disadvantages of the updated Quality Metrics draft guidance on the pharmaceutical industry


Sarah Pope Miksinski, PhD


Industry Perspective
Steven Mendivil

Industry Perspective
Michael G. Davidson

Industry Perspective
Barbara Allen, PhD

Tara Gooen Bizjak, MS

Alex M. Viehmann

avatar for Barbara Allen

Barbara Allen

Senior Director Global Quality Systems, Eli Lilly and Company
Barbara Allen, Ph.D. is Senior Director for Global Quality Systems at Eli Lilly and Company. Dr. Allen has held various positions in API Manufacturing Technical Services, New Product Introduction and Quality Assurance in Ireland and in the USA. She is responsible for integrated GXP... Read More →
avatar for Tara Bizjak

Tara Bizjak

Program Management, OPPQ, OPQ, CDER CDER, FDA
Tara is in the US Public Health Service and a Snr Science Policy Advisor at FDA. She works in the Office of Policy for Pharmaceutical Quality in the area of developing new regs, guidance, and standards for drug manufacturing. Tara has been with the FDA for 15 years, starting as a... Read More →
avatar for Michael Davidson

Michael Davidson

Vice President, Quality Systems and Compliance, Pfizer Inc.
Michael joined Pfizer in 1986 as an analytical chemist, moving to Brussels in 2001 and was responsible for Quality at 6 sites across Europe. Since moving to the US he has held a number of positions, including leading the GMP audit function for sites, suppliers and CMOs and VP of Contract... Read More →
avatar for Steven Mendivil

Steven Mendivil

Senior Advisor International Quality, Amgen Inc.
Steven Mendivil is currently a Senior Advisor in International Quality. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He was previously head of Corporate Quality GMP & EHS and was on the ICH Q11 Expert Working Group and... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER, FDA
Dr. Miksinski received her B.A. from Earlham College (1994) and her Ph.D. from Oklahoma State University (1999). She served as an NIH postdoctoral fellow from 2000-2002, and began as a CMC reviewer at the FDA in 2002. She is now the Acting Director of ONDQA/DNDQA 2.

Alex Viehmann

Operations Research Analyst, OS, OPQ, CDER, FDA

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Session
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  • Credit Type CME, IACET, RN
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